FDA.reportPublic FDA data

MAUDE MDR 4804856

MDR report key
4804856
Report number
1028232-2015-01754
Event key
0
Event type
3
Date of event
2015-04-21
Date received
2015-05-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
6024 JEAN ROAD LAKE OSWEGO OR 97035 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SETROX S 53PACER LEADBIOTRONIK SE & CO. KGNVN350974SEE MODEL NO.R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-2001. H

Event Narratives#

D

Patient 1

THESE LEADS WERE REVISED THE DAY AFTER IMPLANT DUE TO "VERY LITTLE, IF ANY, SLACK LEFT IN THE LEADS NOTED ON X-RAY ON (B)(6) 2015. CONCERN WAS THAT THE LEAD WOULD DISLODGE. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. (REMOVED CORRUPTED DATA FROM THIS REPORT)

N

Patient 1

IT WAS NOTED THAT WHEN THE INITIAL REPORT WAS SUBMITTED TO ESG, THE INFORMATION IN BOX APPEARS TO HAVE BEEN CORRUPTED. WE ARE RE-SUBMITTING THE REPORT TO CORRECT THE ISSUE.

D

Patient 1

THESE LEADS WERE REVISED THE DAY AFTER IMPLANT DUE TO VERY LITTLE, IF ANY, SLACK LEFT IN THE LEADS NOTED ON X-RAY ON (B)(6) 2015. CONCERN WAS THAT THE LEAD WOULD DISLODGE. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

N

Patient 1

THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.